BioAtla, Inc.

Please stand by, your program is about to begin. If you need assistance during your conference today, please press star zero. Good day everyone and welcome to today's BioATLA fourth quarter and fiscal year 2024 earnings call. At this time, all participants are in a listen-only mode. Later, we will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star one on your telephone keypad. you may withdraw yourself from the queue by pressing star two. It is now my pleasure to turn the conference over to Mr. Bruce Mackel of LifeSci Advisors. Please go ahead, sir.

Thank you, operator, and good afternoon, everyone. With me today on the phone from BioAtla are Dr. Jay Short, chairman, CEO, and co-founder, and Richard Waldron, chief financial officer. Following today's call, Dr. Eric Sievers, Chief Medical Officer, and Sherry Lydick, Chief Commercial Officer, will join Jay and Rick in a short Q&A. Earlier this afternoon, BioAtlib released financial results and a business update for the fourth quarter and full year ended December 31, 2024. A copy of the press release and corporate presentation are available on the company's website. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements, including but not limited to statements regarding BioAtlas business plans and prospects and whether its clinical trials will support registration, plans to form collaborations and other strategic partnerships for selected assets, results, conduct, progress, and timing of its research and development programs and clinical trials, expectations with respect to enrollment and dosing in its clinical trials, plans and expectations regarding future data updates, clinical trials, regulatory meetings, and regulatory submissions, the potential regulatory approval path for its product candidates, and expectations about the sufficiency of its cash and cash equivalents to fund operations and expected R&D expenses. These statements are subject to various risks, assumptions, and uncertainties that can cause actual results to differ materially and are described in the filings made with the SEC, including the most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Here are cautions not to place undue reliance on these forward-looking statements, which speak only as of today, March 27, 2025. and BioAtla disclaims any obligation to update such statements to reflect future information, events, or circumstances, except as required by law. With that, I'd like to turn the call over to Dr. Jay Short. Jay?

Thank you, Bruce, and thanks to everyone for joining us for our fourth quarter and full year 2024 BioAtla earnings call. Additional details related to what we will share today are available in today's press release and our updated company presentation, which are available on our website. Also, the posters, which were recently presented at the Mayo Multidisciplinary Head and Neck Cancer Symposium and the European Lung Cancer Congress on our Phase II assets, Zoriftimab-Vedotin, or OSV, and Mecbotimab-Vedotin, or MECB, respectively, are also available on our website. I will begin with updates on our conditionally active biologic or CAB platform clinical programs that we are advancing internally at BioATLA. All of these CAB-based programs are designed to efficiently increase the potency and safety of our therapeutic candidates targeting solid tumors in areas of high unmet medical need. Beginning with our first-in-class dual conditionally binding CAB, EPCAM, and CAB CD3 bispecific T-cell engager antibody. EPCAM is an attractive therapeutic target because it is widely expressed in most solid tumors. However, it has been a difficult target to drug with traditional antibody technologies because it is also widely expressed in normal epithelial tissues. EPCAM's ubiquitous expression in both tumors and normal tissues makes it generally undruggable without a differentiating technology like CABs. Successfully enabling the selective targeting of solid tumors with CAB technology offers the potential for developing one of the first pan-cancer therapies outside of immune checkpoint inhibitors. To date, our dose escalation is progressing well. As hoped, the maximally tolerated dose has not yet been reached, and multiple patients are already experiencing tumor reduction, including one colorectal cancer patient with continued stable disease for more than one year. At present, three patients have received the target dose of 100 micrograms weekly. Two of these three patients have already cleared the dose limiting toxicity period, and the third patient is on track to clear the DLT period on April 8th. We are now also screening patients for the next cohorts who are anticipated to receive the target dose of 300 micrograms. Details about the dosing schematic can be found in our corporate deck. It's worth noting that animal modeling data indicate that significant tumor reduction is expected to occur at target doses of approximately 200 micrograms and above. So we believe that we are reaching exposures where we will start observing formal objective responses. We remain on track for a data readout of the dose escalation portion of the study in mid 2025. We also anticipate a data readout for the cohort expansion portion of the study in the first half of 2026. CAB T-cell engager bispecifics represent a novel approach to harnessing the body's immune system to target and destroy cancer cells, offering the promise of more precise and effective treatment options for cancer patients. We believe our dual CAB EPCAM and CAB CD3 T-cell engager has the potential to be at the forefront of this exciting and powerful approach and has the potential to treat a wide range of metastatic tumors, including cancers of the colon, lung, breast, pancreas, and prostate, among others. Now moving on to CAB-AXL-ADC-McVie. Last quarter, we announced that we are observing ongoing anti-tumor activity with multiple confirmed responses among 21 available patients with tumors expressing in KRAS across nine different KRAS mutations. As part of today's update, we are excited to share promising results from the 1.8 mg per kg Q2W dosing cohort. From the 16 available patients in this cohort, we have observed multiple confirmed responses across different MKRAS variants, while also demonstrating an encouraging clinical benefit risk profile, as well as a patient who had a prior failure of Soto-RAS who experienced a partial response. In addition, a patient who achieved a complete response remains in complete response now for over two years. Importantly, our initial findings for overall survival continue to be compelling as we are now seeing an exceptional overall survival with 66% and 58% of patients with MK-RAS non-small cell lung cancer alive at a landmark of one year and two years respectively. which we believe exceeds what has been observed with the standard of care. The median overall survival has not been reached at 35 months from the first dose, with continued follow-up ongoing. MCV is associated with a generally well-tolerated safety profile, both with and without nivolumab, and no new safety signals have been identified. Notably, the drug-related treatment discontinuation rate was only 7%. We are presenting these data at the European Lung Cancer Congress and encourage you to visit the poster on our website. Based on our evaluation of patients with mutant KRAS non-small cell lung cancer, we continue to observe a high correlation of Axyl and MKRAS expression and believe the mechanistic link between Axyl and MKRAS that drives tumor resistance coupled with the exceptional overall survival that we are seeing in the Q2W dosing cohort supports a potential anti-axle-pan MK-RAS strategy. Now I'd like to pivot to the Phase II clinical programs that we are currently advancing toward corporate partnerships, beginning with our CAB-02-ADC, OZ-V, which is being evaluated as a monotherapy in treatment refractory head and neck cancer patients. Last quarter, we reported an emerging clinical profile in treatment refractory patients with a median of three prior lines of therapy with the potential to become the standard of care in the second line plus head and neck cancer population. Additionally, we shared that we received a fast track designation and actionable guidance from the FDA on our proposed randomized pivotal trial design with OSVI monotherapy versus investigators' choice among patients with recurrent or metastatic head and neck cancer with disease progression on or after platinum-based chemotherapy and PD-1 antibody therapy. As part of today's update, the fully enrolled Phase II study using OSV monotherapy continues to demonstrate new responses in treatment refractory second-line plus head and neck cancer at the 1.8 mg per kg Q2W dosing regimen. We also continued to capture efficacy data for several endpoints, including overall response rate, duration of response, progression-free survival, and overall survival. A particular interest is that we have observed a compelling signal in patients with metastatic HPV positive head and neck cancer. who represent a high unmet need as they are poorly served by agents that inhibit EGFR. These new data, as well as evolving data in the overall head and neck cancer cohort, were presented as a poster today at the Mayo Multidisciplinary Head and Neck Cancer Symposium. To highlight among the 11 patients with HPV positive head and neck cancer treated with 1.8 nigs per kg Q2W, there was 100% disease control rate, a 45% overall response rate, and so far a 27% confirmed response rate with a duration of response greater than 5.3 months that is ongoing. Multiple patients remain on treatment and have the potential to have responses that deepen with time. It is noteworthy that an HPV positive patient achieved a complete response that continues in complete remission, now at greater than 16 months and ongoing. We believe OSB, especially at the 1.8 mg per kg Q2W dose, has been remarkably well tolerated, and there are no new identified safety findings. Further, these results of HPV-positive head and neck cancer are mechanistically supported by recent literature showing that HPV-associated oncogenes upregulate OR2 expression. driving proliferation and invasiveness, thus now providing a compelling rationale for also targeting War II and cancers associated with human papillomavirus infection. We believe our extended experience with Q2W dosing of OSV also has the potential to satisfy Project Optimus requirements, and we plan to share our results with the FDA to seek confirmation regarding our proposed recommended Phase III treatment regimen. We are encouraged by the differentiated findings in second line plus head and neck cancer patients, particularly in both HPV negative and HPV positive patients. For partners, this second line plus population represents a worldwide commercial opportunity of greater than $1 billion in peak sales, with upside opportunity in the first line setting, as well as in other HPV positive cancers. Moving now to our CAB CTLA-4 antibody, Avoustatug. Avoustatug is similar to IPPI with respect to epitope, affinity, and half-life, but differs from IPPI with respect to its ability to avoid binding in the normal tissue environment. As part of today's update, we have dosed a total of 12 patients with unresectable and or metastatic melanoma, eight of whom received five mgs per kg, Three were dose escalated to 10 mg per kg, and one dose escalated all the way to 14.3 mg per kg. While we continue to observe compelling anti-tumor activity with a differentiated safety profile, 10 of the 11 evaluable patients showed tumor reduction, and with the 11 showing no growth to date. Of these 11 evaluable patients with unresectable and or metastatic melanoma treated with the Valsitug in combination with the PD-1 antibody, So far, we observed across multiple doses an overall response rate of 64% and disease control rate of 100%. Notably, we observe a partial response in a patient with acral subungle or under the fingernail melanoma, which is a rare and difficult to treat form of melanoma that generally has a poorer prognosis than cutaneous melanoma. The safety profile of a Valsatug continues to be differentiated with a relatively low incidence and severity of immune-mediated AEs, particularly among patients who receive five meds per kick for less than or equal to 18 weeks in a total of 17 patients. Focusing on these 17 patients, we observed 18% grade three immune-mediated adverse events and no grade four events while maintaining strong efficacy. This safety profile compares favorably to ipilimumab with a reported rate of 40% grade 3 and 4 immune-mediated adverse events. We believe Avalsatug has demonstrated a differentiated clinical profile relative to other CTLA-4 antibodies and has the potential to be best in class. As such, we have recently initiated partnering discussions with the intent to align with a partner that can maximize the value of this asset. Onto our ongoing clinical communications. I am pleased to report our progress with the medical and scientific communities, as acknowledged with numerous publications and presentations at prestigious conferences, including the European Lung Cancer Congress, Mayo Multidisciplinary Head and Neck Symposium, and the American Society of Clinical Oncology. Finally, for our corporate updates, BioAtla is further extending our runway beyond key clinical readouts in the first half of 2026 by streamlining and realigning resources, which includes a workforce reduction of over 30%. We estimate that we will incur approximately $.6 million of one-time cash payments related to the workforce reduction, which will mostly be paid in the second quarter. We intend to retain all employees essential for advancing our two internal priority programs as well as supporting partnering of other clinical assets, which are improving with the ongoing data readouts. I also wish to express my deep appreciation and respect to our employees, both past and present, who have contributed so much with their creativity and hard work to advance these important cures for patients. With that, I would now like to turn the call over to Rick to review the fourth quarter and full year 2024 financials. Rick?